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NDA

CEFAZOLIN SODIUM | N050461 | GLAXOSMITHKLINE

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2019-P-4363 · 8 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of a client pursuant to section 505(j)(2)(C) of the FDC Act requesting that FDA determine that Cefazolin for Injection USP, 2 g vial administered via intramuscular injection, intravenous direct (bolus) injection, and intravenous infusion i	Other	2019-09-18	Granted	Hyman, Phelps & McNamara, P. C.
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2019-P-4362 · 8 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a petition pursuant to section 505(j)(2)(C) of the FDC Act requesting that the FDA determine that Cefazolin for Injection USP in a 3 g vial strength, administered via intramuscular injection, intravenous direct injection, and intraveno	Other	2019-09-18	Granted	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

104 trials from ClinicalTrials.gov — 2 recruiting, 68 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antibioprophylaxis for Excision-graft Surgery in Burn Patient (A2B-TRIAL)NCT04292054	Phase 3	Recruiting	Assistance Publique - Hôpitaux de Paris	506	2020-10-11 → 2026-07-09
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery NCT02996656	N/A	Recruiting	Université de Montréal	88	2016-12 → 2026-12
Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated Peritonitis NCT02872038	Phase 4	Completed	Chulalongkorn University	154	2015-08 → 2016-11-30
Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection NCT01191840	Phase 2	Completed	Duke University	509	2011-02 → 2017-03-04
Trial Comparing the Optimal Timing of Antibiotic Prophylaxis at the Time of Cesarean Delivery NCT00811603	Phase 3	Completed	MemorialCare	50	2008-08 → 2009-09
Prophylactic Antibiotic Use in Hernioplasty NCT00636831	Phase 3	Completed	Nihon University	400	2007-07 → 2012-01
Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy NCT00818766	N/A	Completed	Brigham and Women's Hospital	251	2008-03 → 2011-04
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)NCT01479283	Phase 3	Completed	McMaster University	602	2013-01 → 2021-03
Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections NCT03426761	Phase 4	Completed	Infectious Diseases Physicians, Inc.	41	2018-01-25 → 2022-12-31
Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection NCT03595852	N/A	Completed	University of Rwanda	138	2018-03-01 → 2019-03-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain4 active DMFs12 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ACS DOBFAR SPACEFAZOLIN SODIUM LYOPHILIZED (STERILE, BULK)

DMF 132081998

SANDOZ GMBHCEFAZOLIN SODIUM (STERILE)

DMF 141331999

ORCHID PHARMA LTDCEFAZOLIN USP

DMF 150222000

ORCHID PHARMA LTDCEFAZOLIN SODIUM, USP (STERILE BULK)

DMF 161342002

HOECHST AGInactiveCEFAZOLIN SODIUM INJECTION (STERILE FILLING)

DMF 67841987

GEMA SAInactiveCEFAZOLIN

DMF 81371989

BIOCHEMIC GESELLSCHAFT MBHInactiveCEFAZOLIN

DMF 86341990

BIOCHIMICA OPOS 2 SPAInactiveCEFAZOLIN SODIUM, BULK

DMF 101301986

ASTELLAS PHARMA INCInactiveCEFAZOLIN

DMF 101561991

ACS DOBFAR SPAInactiveCEFAZOLIN SODIUM

DMF 136901998

BRISTOL MYERS SQUIBB COInactiveCEFAZOLIN SODIUM

DMF 137071998

BRISTOL MYERS SQUIBB COInactiveCEFAZOLIN SODIUM

DMF 137501998

TEVA PHARMACEUTICALS USA INCInactiveCEFAZOLIN SODIUM

DMF 137411998

ASTELLAS PHARMA INCInactiveCEFAZOLIN SODIUM (STERILE)

DMF 137971998

AUROBINDO PHARMA LTDInactiveCEFAZOLIN SODIUM USP

DMF 183862005

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFAZOLIN SODIUM (STERILE)

DMF 245272011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 11, 2005	SUPPL -138	View Letter (PDF)
Jun 7, 2004	SUPPL -139	View Letter (PDF)
Jan 22, 2004	SUPPL -135	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴